摘要
目的 建立气相色谱法测定美金刚(盐酸美金胺)的溶出度和含量的方法。方法药品碱化后用正己烷萃取。采用BP-5(30m×250μm)气相色谱柱,柱温为程序升温,氢火焰离子化检测器(FID),分流比5:1。用萘作内标,以内标法峰面积定量。结果盐酸美金刚在10～120mg·L-1内进样量与峰面积呈线性关系,平均回收率为99.4%,RSD为1.05%(n=12)。结论本方法简便、准确、重现性好,可作为本制剂的质量控制方法。
Abstract
OBJECTIVE To determine the conetent of memantine hydrochloride tablets and its dissolution by GC.METHODS The sample was extracted with hexane. The content of memantine hydrochloride was detected with hydrogen flame ionization detector (FID) after the separation on a BP-5 column(30 m×250μm) .Column temperature was increased by programmed control and split flow was 5:1. Naphthalene was used as the internal standard. RESULTS The calibration curve was linear over the range of 10～120 mg·L-1. The average recovery was 99.4% , RSD was 1.05% (n = 12) . CONCLUSION This method was proved to be simple, accurate, reliable and reproducible.
关键词
气相色谱法 /
盐酸美金刚 /
溶出度
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Key words
GC /
memantine hydrochloride /
determination
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李迎;曹树贵;梅兴国.
气相色谱法测定盐酸美金刚片的含量和溶出度[J]. 中国药学杂志, 2005, 40(22): 1743-1744
LI Ying;CO Shu-gui;MEI Xing-guo.
Study on determination and dissolution of memantine hydrochloride tablets by GC [J]. Chinese Pharmaceutical Journal, 2005, 40(22): 1743-1744
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参考文献
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[2］Suckow FR，Zhang FM，Collins DE，et al. Sensitive and selective liquid chromatographic assay of mementine in plasma with fluorescence detection after pre-column derivatization[J］.J Chromatogr B，1999，729：217.
[3］Freudenthaler S，Meineke I，Schreeb HK，et al.Influence of urine pH and urinary flow on the renal excretion of memantine [J］.Br J Clin Pharmacol，1998，46：541.
[4］Nurnberg E， Seiller E， Ritsert S. Memantine-containing solid pharmaceutical dosage forms having an extended two-stage release profile and production thereof[P］. USP：5382601，1995-1-17.
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脚注
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